Pozen has taken another step toward the regulatory approval of a new arthritis treatment. The Chapel Hill, NC biotech says that PN 400--which is partnered with AstraZeneca--produced new data supporting its efficacy and hit its endpoints in two studies. Patients taking the drug developed fewer gastric ulcers than people taking the painkiller naproxen. Researchers have been tracking 800 patients who had taken the treatment for six months.
PN 400 is a combo therapy that mixes naproxen with AstraZeneca's Nexium. The developers are hoping to file for FDA approval next year. The FDA has been reviewing whether it would accept ulcer rates as a primary endpoint. An internal review is scheduled for the first quarter of 2009.
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